Description

Duloxetine Impurity 8 is a designated process-related impurity and reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Duloxetine Hydrochloride. This compound is critical for ensuring the purity, safety, and regulatory compliance of the final drug product by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, validation, and batch release of antidepressant and neuropathic pain medications.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Duloxetine Impurity 8 in Duloxetine API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities.
• Quality Control & Batch Release Testing: Employed in routine QC testing to ensure API batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B impurity limits.
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability studies of the drug substance and product.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthetic pathway to minimize the formation of this impurity.

Basic Information

Product Name	Duloxetine Impurity 8
CAS No.	2292353-17-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Duloxetine Related Compound 8; (S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine Impurity; Duloxetine EP Impurity H; Duloxetine USP Impurity; 1-Naphthalenol, 3-[(methylamino)methyl]-3-(2-thienyl)-, (3S)-; (S)-3-(Methylamino)-1-(naphthalen-1-yloxy)-1-(thiophen-2-yl)propan-1-ol
EINECS	Contact for details

Quality Control

Our Duloxetine Impurity 8 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay results, and analytical methods. We support compliance with ICH guidelines and major pharmacopeias.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity. Keep the container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.